REVA Medical Announces Interim Clinical Results at EuroPCR
21 Maio 2012 - 5:45PM
REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company"), announced
at the European Course on Revascularization, the largest European
stent meeting held last week in Paris, France, that there were no
reported Major Adverse Coronary Events (MACE) on 16 patients who
were enrolled in the Company's RESTORE trial, with no incidences of
ischemic target lesion revascularization (TLR), myocardial
infarction (heart attack) or stent thrombosis. The first enrolled
case is approaching 5 months and all patients enrolled in the study
continue to do well.
Reporting on the results of the RESTORE clinical trial was
Principal Investigator, Alexandre Abizaid, MD from Sao Paulo's
Dante Pazzanese Institute de Cardiologia, who implanted the first
ReZolve® scaffold in December 2011. "I am pleased to inform the
cardiology community at EuroPCR of the early success and clinical
experience with REVA's ReZolve scaffold. In this preliminary
analysis, the device has demonstrated its ability to maintain lumen
patency during the critical early healing period, and this
experience was noted across several sites and investigators." In
addition, Dr. Abizaid announced that REVA would be moving to an
approximately 20% lower profile sheathless delivery system (6Fr
guide compatible), called ReZolve2, for the upcoming CE Mark
Trial.
The Company adopted a pilot trial strategy with very tight
patient inclusion criteria to ensure patient safety, yet provide
enough enrolled patients to demonstrate sufficient product
performance. After carefully reviewing patient data generated to
date, the Company has concluded that the current patient cohort
reported upon has met the objectives of the pilot trial; the
Company will continue to enroll more patients in the pilot trial
through the second quarter of 2012, but will conclude enrollment in
the pilot trial no later than June 30, 2012.
"We are very pleased with the results to date in the RESTORE
pilot study," commented REVA's CEO, Bob Stockman. "The scaffold is
performing well and physicians commented that they appreciated
ReZolve's visibility under x-ray as well as the scaffold's sizing
range, two very distinctive features of ReZolve's fully
bioresorbable polymer scaffold. ReZolve2 is a thinner more easily
deliverable device because it does not require a protective sheath.
We believe that by improving deliverability we will significantly
speed up the rate of patient enrollment in our upcoming CE trial.
ReZolve2 will be the product we commercialize."
The next important milestone for REVA will be the 6-month
clinical evaluation of the first cohort of patients, which will be
reported at October's Transcatheter Cardiovascular Therapeutics
Conference ("TCT").
The presentation given by Dr. Alexandre Abizaid at the EuroPCR
conference on Thursday, May 17, 2012, is available on the Company's
website at www.revamedical.com.
About REVA
REVA is a development stage medical device company incorporated
in Delaware, USA that is focused on the development and eventual
commercialisation of its proprietary, bioresorbable stent products.
REVA's principal product, the ReZolve® scaffold, combines REVA's
proprietary stent design with a proprietary polymer that is
metabolized and cleared from the body. The ReZolve scaffold is
designed to offer full x-ray visibility, clinically relevant sizing
and a controlled and safe resorption rate. In addition, by early
encapsulation of the stent in the artery tissue coupled with the
loss of scaffold structure over time, the ReZolve scaffold may
reduce the incidence of late forming blood clots, or thrombosis, a
rare but serious problem associated with drug-eluting metal stents
currently on the market. REVA will require clinical results and
regulatory approval before it can begin selling the ReZolve
scaffold.
The REVA Medical, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8505
Forward-Looking Statements
This announcement contains or may contain forward-looking
statements that are based on management's beliefs, assumptions and
expectations and on information currently available to management.
All statements that are not historical, including those statements
that address future operating performance and events or
developments that we expect or anticipate will occur in the future,
are forward-looking statements. You should not place undue reliance
on these forward-looking statements. Although management believes
these forward-looking statements are reasonable as and when made,
forward-looking statements are subject to a number of risks and
uncertainties that may cause our actual results to vary materially
from those expressed in the forward-looking statements, including
our ability to obtain the regulatory approvals required to market
our ReZolve scaffold, our ability to timely and successfully
complete our clinical trials, our ability to protect our
intellectual property position, our ability to commercialize our
products if and when approved, our ability to develop and
commercialize new products, and our estimates regarding our capital
requirements and financial performance, including profitability.
Other risks and uncertainties that may cause our actual results to
vary materially from any forward-looking statements are described
in the "Risk Factors" section of our Annual Report on Form 10-K
filed with the United States Securities and Exchange Commission
(the "SEC") on February 28, 2012, as updated in our Quarterly
Report on Form 10-Q filed with the SEC for the period ended March
31, 2012. We may update our risk factors from time to time in our
periodic reports or other current reports filed with the SEC. Any
forward-looking statements in this announcement speak only as of
the date when made. REVA does not assume any obligation to publicly
update or revise any forward-looking statements, whether as a
result of new information, future events, or otherwise.
CONTACT: United States
Investor and Media Enquiries:
Cheryl Liberatore
Director, Investor Relations and Marketing
REVA Medical, Inc.
+1 858 966-3045
Australia
Investor Enquiries:
David Allen or Alan Taylor
Inteq Limited
+61 2 9231 3322
Media Enquiries:
Katie Mackenzie or Rebecca Wilson
Buchan Consulting
+61 3 9866 4722
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